Theranos Ran Tests Despite Quality Problems

March 7, 2016 20:08 EST: Theranos Ran Tests Despite Quality Problems

By John Carreyrou and Christopher Weaver

A federal inspection report said a Theranos Inc. laboratory ran an important blood test on 81 patients in a six-month period despite erratic results from quality-control checks meant to ensure the test’s accuracy, people familiar with the report said.

The report hasn’t been publicly released but is far more detailed than the letter that summarized the results of last fall’s inspection of the Newark, Calif., lab by the federal Centers for Medicare and Medicaid Services and was sent to Theranos in late January, these people said.

That letter cited “deficient practices” in five categories. In one of them, hematology, the problems found by inspectors posed “immediate jeopardy to patient health and safety,” regulators said.

The test that inspectors found Theranos kept doing despite the erratic quality-control results was a hematology test that measures how long it takes blood to clot, the people familiar with the matter said.

The test is an important part of the treatment regimen for patients who are at risk of strokes or have blood disorders.

Inaccurate results from the test can be especially serious for patients taking blood thinners such as warfarin, also known by its brand name Coumadin. Too much warfarin can cause fatal bleeding, while too little can leave patients vulnerable to clots and strokes, according to medical experts.

People who have seen the Theranos inspection report said it seems to indicate the company ignored quality-control results for the blood-clotting test that fell short of its own criteria.

The results produced in the quality-control checks repeatedly deviated from the lab’s typical result by more than two standard deviations, those people said.

The erratic quality-control results occurred between April 1 and Sept. 23, 2015, the people said. Despite those problems, inspectors found that Theranos sent blood-test results to the 81 patients, according to the people familiar with the report.

“We have conducted assessments to identify any patients affected or having the potential to be affected by the issues identified by CMS, and we have no reason to believe that these issues have affected patients’ health,” said Kingshuk Das, director of Theranos’s lab in California.

Dr. Das added: “At its heart, the CMS report is about people and processes in one Theranos lab in the past, and does not reflect the current state of that lab.” Theranos, based in Palo Alto, Calif., and one of the highest-profile startups in Silicon Valley, was founded by Elizabeth Holmes and has another lab in the Phoenix area.

Some deviation in quality-control test results is normal, and labs set their own ranges for how much variation to tolerate, lab directors said. Most laboratories use the two-standard-deviation criterion, according to those lab directors.

To ensure the accuracy of the blood-clotting test, called “prothrombin time,” labs typically run several quality-control checks each day. These checks often involve performing the test on a sample of preserved blood plasma with a predictable result to see if the lab’s test matches the expected outcome.

The Theranos lab was using machines made by Siemens AG to perform the prothrombin time test, people familiar with the report said. To help gauge accuracy, the lab used a preserved blood product from Siemens called Ci-Trol Coagulation Control Level 3.

Labels for Siemens prothrombin time testing products recommend that labs that see aberrant quality-control results refrain from reporting patient data until documenting and correcting possible problems.

At Theranos, there were seven quality-control failures in a single day, said a person familiar with the report.

The agency’s findings for the blood-clotting test were detailed in a section of the inspection report titled “Failure to Ensure that QC Test Results Met the Lab’s Criteria for Acceptability,” according to the people who saw the report.

Timothy Hamill, professor emeritus at the University of California, San Francisco’s department of laboratory medicine, said continuing to test live patient samples despite repeated quality-control failures is a serious breach of the protocols used by labs to ensure test accuracy.

Dr. Hamill said any doctors who received prothrombin time test results from the Theranos lab during the six-month period shouldn’t rely on them and should have their patients retested as soon as possible. “Those results are not worth anything,” he said.

Ms. Buchanan of Theranos said the company “has notified any potentially affected patients.”

Vanderbilt University cardiologist Christopher Ellis said inaccurate results could lead doctors to increase or decrease warfarin doses. Such changes would likely be made cautiously, he added, and an inaccurate test result wouldn’t necessarily result in harm to the patient.

Still, some patients are predisposed to respond more dramatically to the drug than other patients, and even small dosage changes based on faulty tests could be dangerous, he added.

The federal inspectors also concluded that the Theranos lab in California used expired reagents, or substances added to blood samples to elicit chemical reactions, for some prothrombin time tests, according to the people familiar with the inspection report.

Those people said the report also found that the lab’s director didn’t have responsibility for the lab’s quality-control program and the lab’s quality-control manager was unqualified. Theranos has since hired Dr. Das as a new lab director.

CMS warned Theranos in late January that the California lab could lose its certification if it didn’t remedy the problems promptly. The agency is reviewing a formal plan of correction submitted by Theranos last month.

The company has asked CMS not to publicly release the inspection report on the grounds that doing so would compromise Theranos trade secrets, according to people familiar with the company’s position. The agency usually makes inspection findings public after a period of time.

Write to John Carreyrou at john.carreyrou@wsj.com and Christopher Weaver at christopher.weaver@wsj.com

Breaking the story

John Carreyrou and Christopher Weaver were first to report a federal inspection on Theranos found that the lab company continued to run blood tests on patients during a six-month period despite erratic quality-control results.

Email *Please fill in the required field. By clicking submit, I agree to the Privacy Policy and Cookie Policy and I understand I will receive marketing communications from Dow Jones professional information products from which I may unsubscribe using the links provided.

Thank you

Thank you for subscribing, your information has been submitted successfully.